Devices
FDA has published a draft guidance, Translation of GLP Study Reports: Questions and Answers, with information for sponsors and non-clinical laboratories about the language translation of study reports for studies conducted in compliance with good laboratory practice (GLP) regulations. The document says GLP studies include nonclinical toxicology studies, safety
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it is concerned by an FDA proposal to eliminate the parallel interchangeability statement and footnote currently in the labeling of some biosimilar products listed as interchangeable. The proposal is part of an agency draft guidance on labeling for biosimilar and interchangeable biosimilar
Drugs
A 2/6-2/17 FDA inspection at the Cipla drug manufacturing facility in Madhya Pradesh, India, found repeat significant current good manufacturing practice (CGMP) violations for finished drugs. An 11/17 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch
Devices
SoClean has recalled its SoClean2 and SoClean3 equipment that is used to clean, sanitize, or disinfect CPAP sleep apnea devices and accessories. The recall comprises a new User Manual with additional instructions for use and a hose and mask adapter that is intended to help reduce potential health risks of
Drugs
Writing in National Law Review, three Epstein Becker Green attorneys say medical product manufacturers should study an FDA 2023 draft guidance on sharing scientific information with healthcare providers on unapproved uses of medical products “to mitigate potential risk in navigating the often murky regulatory waters of engaging in off-label
Drugs
A 12/6-12/15/2022 FDA inspection at a clinical trial site operated by Dr. Melanie Hoppers/Physicians Quality Care in Jackson, TN, found objectionable conditions in the conduct of two clinical investigations. An 11/8 Warning Letter says it appears that Hoppers did not adhere to the applicable
FDA Policy/General
FDA commissioner Robert Califf says some postmarketing evidence-generating studies are so important that they may need public funding to ensure they get completed. Speaking in a Yahoo! Finance video interview, Califf says he prefers to consider postmarketing evidence-generation as a way of looking forward rather than looking back.
Drugs
Bayer is recalling one lot of Vitrakvi (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles, indicated for treating solid tumors that are NTRK gene fusion positive, due to microbial contamination identified as Penicillium brevicompactum that was detected during routine stability testing. While there are limited data on human
Drugs
A bipartisan group of nine senators led by Sen. Rand Paul (R-KY) is asking FDA for information on the specific steps the agency is taking to update its animal testing regulations and the timeline for the implementation of a revised regulatory framework under the FDA Modernization Act 2.0.
Devices
FDA has approved a Medtronic PMA for its Symplicity Spyral renal denervation system for treating hypertension. The device works by delivering radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood pressure. The therapy is administered by catheter in the artery leading to the
Drugs
FDA has delayed a 12/16-expected review decision on a Bristol Myers Squibb and 2seventy bio supplemental BLA for Abecma (idecabtagene vicleucel) and its use in earlier lines of triple-class exposed relapsed or refractory multiple myeloma (RRMM). The agency has elected to seek input from its Oncologic Drugs
FDA Policy/General
Federal Register notice: FDA is announcing a 12/14 public meeting entitled “Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement.” The workshop is intended to focus on how best to understand patients’ experiences living with a rare disease and how to incorporate those experiences, as well as
FDA Policy/General
Federal Register notice: FDA is requesting information to better understand the status of trading partners’ (manufacturers, wholesale distributors, dispensers, and repackagers) interoperable systems and processes for enhanced drug distribution security. The agency says that trading partners should be using the current stabilization period to continue to build and validate secure,
FDA Policy/General
A new FDA final rule sets five standards that the agency says drug marketers must follow to ensure their direct-to-consumer advertisement’s “major statement” is presented in a clear, conspicuous, and neutral manner. The rule, Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a
Drugs
Bayer says it is stopping its Phase 3 OCEANIC-AF study evaluating asundexian compared to apixaban (Bristol-Myers Squibb’s Eliquis) in patients with atrial fibrillation at risk for stroke due to an “inferior efficacy” comparison. The decision is based on the recommendation of the study’s independent data monitoring
Devices
FDA is warning healthcare professionals not to use Cardinal Health Monoject syringes with syringe pumps and patient-controlled analgesia (PCA) pumps while the agency further evaluates their compatibility with the devices. Recently, Cardinal Health recalled the syringes because their dimensions differ from the previously branded syringes and they may be
Drugs
Janssen Pharmaceutical has submitted a supplemental BLA for Rybrevant (amivantamab-vmjw) in combination with chemotherapy (carboplatin and pemetrexed) for treating patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution after disease progression on or
Drugs
FDA has issued Dr. Reddy’s Laboratories a 10-item Form FDA-483 after concluding an inspection 10/27 at the firm’s Telangana, India manufacturing facility. Agency investigators cited Dr. Reddy’s for not maintaining/cleaning equipment and utensils at appropriate intervals. They also took issue with the facility’
FDA Policy/General
Federal Register notice: FDA is making savailable a final guidance entitled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act” and a draft guidance entitled “Select Updates for the 506J Guidance: 506J Device List and Additional Notifications.
FDA Policy/General
Federal Register notice: FDA is announcing a 2/6/2024 meeting of the Medical Devices Advisory Committee’s General Hospital and Personal Use Devices Panel. It is scheduled to discuss and make recommendations on medical device supply chain resiliency and shortage issues, including the agency’s “506J Device List.” Manufacturers
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Assessing the Credibility of Computational Modeling and Simulation (CM&S) in Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff.” The document provides a risk-informed framework for credibility assessment of CM&S used
Drugs
FDA has approved an AstraZeneca NDA for Truqap (capivasertib) for use with fulvestrant in adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test